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Thursday, August 26, 2021

Inovio to start COVID-19 vaccine trial after Brazil regulator's nod

 Inovio Pharmaceuticals Inc said on Thursday it would start a large study for its experimental COVID-19 vaccine, after the drugmaker received authorization from Brazil's regulatory agency.

Earlier this year, Inovio decided to conduct the efficacy segment of its mid-to-late-stage trial outside the United States, after the U.S. Food and Drug Administration (FDA) put a part of the U.S. study on hold for more information on the vaccine delivery device.

The FDA's decision was followed by the U.S. government pulling funding for the late-stage part of the study due to vaccines being available in the country.

Inovio will conduct the global efficacy trial in partnership with China's Advaccine Biopharmaceuticals in areas of the world in need of COVID-19 vaccines, the company said in a statement.

Inovio, which has no approved drug in the market, has so far received about $85 million in combined funding from the Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation and the U.S. Department of Defense for the advancement and manufacture of INO-4800. 

https://finance.yahoo.com/news/1-inovio-start-covid-19-123117450.html

Older people ‘more likely to engage with digital physiotherapy care’

 Researchers in the US have found that older people are far more likely to engage with digital physiotherapy programmes digitally than those in younger age groups.

Gen Xers, working-age baby boomers and retirees – collectively the over-41 age bracket – were more likely to start a musculoskeletal (MSK) programme delivered via digital channels than Gen Zers and millennials, according to Hinge Health, whose back and joint pain programme was used in the study.

The higher level of engagement could be due to greater appreciation of the convenience of receiving care at home, as well as mobility or transportation challenges that may be more prevalent in older people.

It could also be because older people tend to pay more attention to their MSK pain, and are more motivated to take steps to tackle it. Either way, the results undermine the idea that older people might be less likely to use this type of telehealth intervention because they are less ‘tech-savvy’.

The study – which involved more than 41,000 Medicare participants – found that retirees were the most engaged, completing 19 more exercise therapy sessions, accessing 11 more articles, and sending five more messages to the clinical team compared to Gen Zers and millennials.

“Evidence suggests that older adults may respond better than younger adults to exercise counselling and education similar to that offered by the programme,” write the researchers in the journal Frontiers in Digital Health.

The study also found however that older generations needed to do more exercise and read more articles to achieve similar changes in pain as younger participants.

Older subjects also reported higher rates of anxiety improvement at 12 weeks, which could reflect the digital health programme’s focuses on MSK-related issues like fall prevention.

“This study debunks a myth that older populations don’t actively engage in digital care,” commented Hinge Health’s chief medical officer Dr Jeffrey Krauss.

“These findings are consistent with other studies showing that older adults who choose to use a digital MSK programme are actually even more engaged than younger adults.

Hinge Health’s programme includes modules for prevention and treatment of back and joint problems, including guided physical therapy and educational and behavioural support, and for some applications can include the use of wearable motion sensors and pain relief devices.

https://pharmaphorum.com/news/older-people-more-likely-to-engage-with-digital-physiotherapy-care/

California looking to pay drug addicts to stay sober

 Frustrated by out-of-control increases in drug overdose deaths, California’s leaders are trying something radical: They want the state to be the first to pay people to stay sober.

The federal government has been doing it for years with military veterans and research shows it is one of the most effective ways to get people to stop using drugs like cocaine and methamphetamine, stimulants for which there are no pharmaceutical treatments available.

It works like this: People earn small incentives or payments for every negative drug test over a period of time. Most people who complete the treatment without any positive tests can earn a few hundred dollars. They usually get the money on a gift card.

It’s called “contingency management” and Gov. Gavin Newsom has asked the federal government for permission to use tax dollars to pay for it through Medicaid, the joint state and federal health insurance program for the poor and disabled that covers nearly 14 million people in California.

Meanwhile, a similar proposal is moving through California’s Democratic-controlled Legislature. It’s already passed the Senate with no opposition and is pending in the Assembly, where it has a Republican co-author.

“I think there is a lot in this strategy for everyone to like,” said state Sen. Scott Wiener, a Democrat from San Francisco and author of the bill. “Most important of all, it works.”

How much it would cost depends on how many people participate. A program covering 1,000 people could cost as much as $286,000, a pittance in California’s total operating budget of more than $262 billion.

The San Francisco AIDS Foundation, a nonprofit agency, runs a small, privately-funded contingency management program. It’s where Tyrone Clifford, who was addicted to meth, enrolled because they promised to pay him for every negative test over 12 weeks.

His first payment was $2. That increased slightly with each subsequent negative test for a total of about $330.

“I thought, I can do 12 weeks. I’ve done that before when my dealer was in jail,” he said. “When I’m done I’ll have 330 bucks to get high with.’”

Clifford did make it through the program without a positive test. But instead of using the money to buy more drugs, he bought a laptop computer so he could go back to school. He says he hasn’t used methamphetamine in 11 years and now works as a counselor at the San Francisco AIDS Foundation, helping people who had the same addiction problems he did.

Clifford, 53, said earning the money didn’t matter much. Unlike some who struggle with drug addiction, Clifford always had a job and a house and was never much in danger of losing either. But he said watching his account grow with each negative test motivated him more than any other treatment program did.

“You watch those dollar values go up, there is proof right there that I am doing this,” he said. “By no means is anyone getting rich off this program.”

There is “clear and convincing evidence” that the treatment works to keep people sober from drugs like methamphetamine and cocaine, according to an analysis by the California Health Benefits Review Program. However, while research shows it is effective in keeping people sober during the program, the effect doesn’t last much beyond six months after treatment concludes.

Clifford acknowledged the program doesn’t work for everybody, but added his treatment included extensive group and individual counseling sessions that kept him accountable and made him feel part of a community.

Clifford said he considers the treatment a success even if people don’t make it without a positive test.

“They are trying something,” he said.

If California starts paying for contingency management treatment through Medicaid, Clifford said he thinks it would mean an explosion in similar programs across the state.

California, like most of the country, has struggled with opioid abuse, including drugs like prescription painkillers and heroin. But overdose deaths from stimulants in California nearly quadrupled between 2010 and 2019, and the problem has gotten even worse since.

Preliminary data from the first nine months of 2020 — when much of the state was locked down because of the coronavirus— shows stimulant overdose deaths jumped 42% compared to 2019.

While opioids have several pharmaceutical treatments available to help people get sober, there are none for stimulants like methamphetamine and cocaine, often leaving people to their willpower to kick the habit.

“There is a clear kind of hole in regards to treatment services for individuals who have a stimulant use disorder,” said Jaycee Cooper, director of California’s Medicaid program. “At this point (contingency management) is the only thing people are pointing to that has been effective.”

Contingency management is not widely used because it’s not clear if state and federal law allow Medicaid money to pay for it. California has a law prohibiting people from profiting or receiving “kickbacks” from treatment programs. Wiener’s law would clarify contingency management is legal under state law.

Whether it violates federal law is still a question.

“We don’t think it does,” Wiener said, noting the Biden administration has signaled its interest in the treatment.

Wiener’s bill would require California’s Medicaid program to pay for the treatment while Newsom’s plan would let counties choose whether to participate.

https://apnews.com/article/health-california-d9d057b32c0715404aa7a5d08b014059

Molecular Partners Reports Corporate Highlights, Key Financials for H1 2021

 Significant progress in COVID-19 trials, including positive results from healthy subjects and COVID-19 patients, supporting the launch of ongoing late-stage trials EMPATHY and ACTIV-3

Research & Development:

  • Initiated two global Phase 2 and 3 trials of ensovibep (MP0420), to explore safety and efficacy in ambulatory patients with COVID-19 (EMPATHY) in collaboration with Novartis, and hospitalized patients (ACTIV-3) sponsored by the National Institutes of Health (NIH)

  • Received FDA Fast Track designation for ensovibep for the treatment of COVID-19 in both hospitalized and ambulatory settings

  • Initiated and fully enrolled Phase 2a single arm study of ensovibep in the Netherlands in patients with mildly symptomatic COVID-19, with data expected to be presented in a scientific conference in H2 2021

  • Reported that in vitro studies indicate that ensovibep maintains potency against all known SARS-CoV-2 variants of concern, including Delta and Lambda

  • Presented data further supporting the MP0317, T-cell engager, and Peptide-MHC oncology programs at AACR

  • In August, announced receipt of global rights of abicipar pegol for the treatment of neovascular AMD (nAMD) and Diabetic Macular Edema, following termination of license and collaboration agreement by AbbVie Inc.

U.S. data show rising 'breakthrough' infections among fully vaccinated

 Some 25% of SARS-CoV-2 infections among Los Angeles County residents occurred in fully vaccinated residents from May through July 25, a period that includes the impact of the highly transmissible Delta variant, U.S. officials reported on Tuesday.

The data, published in the U.S. Centers for Disease Control and Prevention's weekly report on death and disease, shows an increase in so-called "breakthrough" infections among fully vaccinated individuals.

The CDC is relying on data from cohorts, such as the Los Angeles County study, to determine whether Americans need a third dose of COVID-19 vaccines to increase protection. Government scientists last week laid out a strategy for booster doses beginning on Sept. 20, pending reviews from the U.S. Food and Drug Administration and the CDC.

The new data released on Tuesday involved more than 43,000 reported infections among Los Angeles County residents aged 16 and older. Of them, 10,895, or 25.3%, occurred in fully vaccinated persons, 1,431, or 3.3%, were in partially vaccinated persons, and 30,801, or 71.4%, were in unvaccinated individuals.

The vaccines did, however, protect individuals from more severe cases. According to the study, 3.2% of fully vaccinated individuals who were infected with the virus were hospitalized, just 0.5% were admitted to an intensive care unit and 0.2% were placed on a ventilator.

Among the unvaccinated who fell ill, 7.5% were hospitalized, 1.5% were admitted to an intensive care unit and 0.5% required breathing support with a mechanical ventilator.

In addition to the LA County data, the CDC on Tuesday released an update on the HEROES cohort study among healthcare workers that showed a significant drop in vaccine effectiveness among vaccinated frontline workers in eight states who became infected with the coronavirus.

Vaccine efficacy during the period of the study when Delta was predominant fell to 66% from 91% prior to the arrival of the Delta variant, according to the report.

https://uk.sports.yahoo.com/news/u-data-show-rising-breakthrough-181453866.html

Kroger plans to give 1 million COVID booster shots per week

 Kroger, the nation's largest grocery chain, says it is making plans to administer 1 million COVID-19 booster shots each week once the jabs are available, and the company will even offer the jabs at nursing homes to residents unable to venture out according to a report.


President Colleen Lindholz revealed the ambitious goal to Reuters in an interview, saying the number of shots would be administered at double the rate the company delivered initial doses of the shot during the pandemic's peak.

"When the vaccine first came out, we were not included in the long-term care facility deployment, but it's great this time that we can be a part of that," Lindholz said. "We've reached out to facilities that we already deliver prescriptions to, or where we've done flu shot clinics in the past."

Kroger didn't immediately respond to an inquiry from FOX Business about the plans.

While the booster shots have not yet been given the green light from the feds for broad distribution, certain immunocompromised Americans became eligible for a third dose of Pfizer or Moderna mRNA vaccines earlier this month. The boosters could possibly be given the all-clear by health officials and made available to the general public by mid-September.

The Pfizer-BioNTech vaccine is currently the only one that has been granted full FDA approval, and just for its first two doses. The companies said that they have initiated an application for full approval of their booster shot for ages 16 and older and have plans for the application to be completed by the end of the week.

https://www.foxbusiness.com/markets/kroger-plans-give-1-million-covid-booster-shots-per-week

France to roll out COVID booster shots in nursing homes from Sept 12-13

 France plans to roll out COVID-19 vaccine booster shots in nursing homes from September 12 or September 13 onwards, Prime Minister Jean Castex said on Thursday.

Meanwhile, people aged over 65 and those will existing medical conditions will be able to book appointments for a booster shot from early September, Castex told RTL radio, adding there must be a six-month delay between the second and the third shot.

France's Haute Autorite de Sante (HAS) health watchdog on Tuesday recommended a COVID-19 vaccine booster shot for those aged 65 and over and for those with existing medical conditions that could put at them serious harm from COVID. 

https://news.trust.org/item/20210826062224-wx5r1/